Brief Title
Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
Official Title
Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
Brief Summary
Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm (AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm. Aneurysms that remain pressurized despite EVAR may continue to grow, therefore requiring additional surgical interventions. The purpose of this study is to infer the reduction of pressure transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to assess the pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction in aneurysm wall pulsatility after EVAR will correlate with improved aneurysm sac size reduction.
Detailed Description
Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm (AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm. Unfortunately, this procedure is not always successful, and patients need to return to the operating room for further procedures because the aneurysm wall remains pressurized and the aneurysm continues to grow. Currently, there is no standard non-invasive way of measuring aneurysm pressure. The purpose of this study is to infer the reduction of pressure transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to assess the pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction in aneurysm wall pulsatility after EVAR will correlate with improved aneurysm sac size reduction. This is clinically relevant because physiologic intraoperative feedback of aneurysm pressure may potentially influence surgical decision making in the future, reducing unnecessary re-interventions. This will also improve our understanding of the intraoperative physiologic response to EVAR. Our primary research question is in patients receiving elective endovascular repair of abdominal aortic aneurysms (EVAR), does the change in intraoperative ultrasound estimated aneurysm wall pressure during EVAR correlate with aneurysm sac size reduction 1 year after surgery? Secondary objectives are to assess correlation between intraoperative ultrasound estimated aneurysm wall pressure and endovascular leaks and aneurysm-related re-interventions. A prospective, observational, assessor-blinded and surgeon-blinded study will be conducted at the TOH Civic Campus in Ottawa, ON in order to satisfy the objectives of the study.
Study Type
Observational
Primary Outcome
Fractional aneurysm sac size reduction 1 year after surgery
Secondary Outcome
Fractional aneurysm sac size reduction 30 days after surgery
Condition
Abdominal Aortic Aneurysm
Intervention
Abdominal Aortic Aneurysm Sac Pulsatility
Study Arms / Comparison Groups
EVAR Patients
Description: Patients with infrarenal abdominal aortic aneurysm scheduled for elective endovascular aneurysm repair (EVAR) surgery will undergo intraoperative assessments of aneurysm wall pulsatility using ultrasound M-Mode.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
20
Start Date
August 9, 2019
Completion Date
December 9, 2020
Primary Completion Date
December 9, 2019
Eligibility Criteria
Inclusion Criteria: - Elective endovascular aneurysm repair (EVAR) surgery - Infrarenal abdominal aortic aneurysm - Age greater than 18 years old Exclusion Criteria: - Prior abdominal aortic aneurysm procedures - Inability to visualize aneurysm on ultrasound - Inability to provide consent - Irregular arrhythmias
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 1-613-798-5555, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03993496
Organization ID
20190366-01H
Responsible Party
Principal Investigator
Study Sponsor
University of Ottawa
Study Sponsor
, ,
Verification Date
August 2019